Pharmaceutical packaging for estriol therapy
View Patent ↗This invention relates to novel packaged pharmaceutical products for the treatment of neurodegenerative diseases, such as multiple sclerosis, and methods of using these products.
1. A packaged pharmaceutical product, comprising:
a first region comprising a first series of doses of estriol, wherein each dose of the estriol is co-located with a dose of a progestogen; and
a second region comprising a second series of doses of the estriol that are not co-located with doses of the progestogen; wherein
each dose of estriol comprises about 8 mg of estriol.
2. The packaged pharmaceutical product of claim 1 , wherein each dose of the estriol in the second region is co-located with a dose of placebo.
3. The packaged pharmaceutical product of claim 1 , wherein each dose of progestogen is co-formulated with a dose of estriol.
4. The packaged pharmaceutical product of claim 1 , wherein the progestogen is a progestin.
5. The packaged pharmaceutical product of claim 1 , wherein the progestogen is progesterone, 17-hydroxyprogesterone, 5α-dihydroprogesterone, norethindrone, norethindrone acetate, desogestrel, levonorgestrel, medroxyprogesterone acetate, megestrol, chlormadinone acetate, cyproterone acetate, norethynodrel, ethynodiol diacetate, norgestrel, gestodene, norgestimate, dienogest, drospirenone, etonogestrel, nestorone, nomegestrol acetate, trimegestone, tanaproget, or a pharmaceutically acceptable salt of any of the foregoing, or any combination thereof.
6. The packaged pharmaceutical product of claim 1 , wherein a dose of the progestogen comprises a dose equal or equivalent to about 100 μg to 1 mg of norethindrone.
7. The packaged pharmaceutical product of claim 6 , wherein a dose of the progestogen comprises a dose equal or equivalent to about 700 μg of norethindrone.
8. The packaged pharmaceutical product of claim 1 , wherein successive doses of the estriol in each series are associated with successive days of an administration cycle, and the administration cycle consists of 28-365 consecutive calendar days.
9. The packaged pharmaceutical product of claim 8 , wherein the administration cycle consists of 4 weeks.
10. The packaged pharmaceutical product of claim 8 , wherein the administration cycle consists of 1 month.
11. The packaged pharmaceutical product of claim 1 , wherein:
the administration cycle consists of 84 consecutive calendar days;
the first region comprises 14 doses each of the estriol and the progestogen; and
the second region comprises 70 doses of the estriol.
12. The packaged pharmaceutical product of claim 11 , wherein the second region comprises a number of doses of the placebo that is equal to the number of doses of the estriol within the second region.
13. The packaged pharmaceutical product of claim 2 , wherein the doses are adapted for oral administration.
14. The packaged pharmaceutical product of claim 13 , wherein the doses of estriol, progestogen, or placebo are provided in a tablet, pill, capsule, or gelcap.
15. A method of treating multiple sclerosis using a packaged pharmaceutical product, the method comprising:
ingesting one dose of an estriol and one dose of a progestogen daily from a first region of the product; and
when the doses in the first region are exhausted, ingesting one dose of estriol daily from a second region of the product;
wherein the product comprises:
a first region comprising a first series of doses of an estriol, wherein each dose of the estriol is co-located with a dose of a progestogen; and
a second region comprising a second series of doses of the estriol that are not co-located with doses of the progestogen; wherein
each dose of estriol comprises about 8 mg of estriol.
16. The packaged pharmaceutical product of claim 11 , wherein the dose of the progestogen comprises a dose equal or equivalent to about 100 μg to 1 mg of norethindrone.
17. The packaged pharmaceutical product of claim 11 , wherein the dose of the progestogen comprises a dose equal or equivalent to about 700 μg of norethindrone.
18. The method of claim 15 , wherein the first series of doses comprises 14 doses each of the estriol and the progestogen; and the second region comprises 70 doses of the estriol.
19. The method of claim 15 , wherein the dose of the progestogen comprises a dose equal or equivalent to about 700 μg of norethindrone.
20. The method of claim 18 , wherein the dose of the progestogen comprises a dose equal or equivalent to about 700 μg of norethindrone.